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Completed

NCT Number: NCT04579497

Temperature-dependent Changes in Cardiovascular Parameters During Warm Water Footbaths in Healthy Women

A study to explore whether different temperatures of warm water footbaths have different effects on the cardiovascular system, the autonomic nervous system and the general well-being of healthy women.

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Arcim Institute

Filderstadt, Baden-Wurttemberg, 70794, Germany

About this study

This is a blinded, four-arm randomized controlled trial with crossover design to explore the effects of warm water footbaths with different water temperatures on cardiovascular stress, reaction of the autonomic nervous system and a feeling of comfort and warmth in healthy female volunteers. Cardiovascular and ANS measurements are performed continuously throughout the interventions and the participants rate their feelings of warmth, general well-being and the footbath-related comfort with questionnaires.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent
  • Age between 18 and 55 years

Exclusion criteria

  • Male sex
  • Chronic skin lesions at the lower legs or feet
  • Varicose veins grade 3 and grade 4 (Marshall stage classification), chronic venous insufficiency
  • Cardiac arrhythmia
  • Cardiac pacemaker
  • Asthma bronchiale
  • Consumption of HRV-modulating medication (especially tricyclic antidepressants, beta blockers)
  • Pregnancy
  • Insufficient knowledge of the German language

Treatment and study plan

38°C warm water footbath

Other

A ten-minute pre-intervention rest period followed by a 30-minute footbath with 16 l of warm water at a constant temperature of 38°C, followed by a ten-minute post-intervention rest period.

40°C warm water footbath

Other

A ten-minute pre-intervention rest period followed by a 30-minute footbath with 16 l of warm water at a constant temperature of 40°C, followed by a ten-minute post-intervention rest period.

42°C warm water footbath

Other

A ten-minute pre-intervention rest period followed by a 30-minute footbath with 16 l of warm water at a constant temperature of 42°C, followed by a ten-minute post-intervention rest period.

38-42°C rising temperature footbath

Other

A ten-minute pre-intervention rest period followed by a 30-minute footbath with 16 l of warm water. Water temperature starts at 38°C and is increased by 1°C every 6 minutes, resulting in 42°C after 30 minutes. The footbath is followed by a ten-minute post-intervention rest period.

Primary outcomes

  1. Pressure Rate Product (PRP) at timepoint t5 (footbath minute 21-30)

    Time frame: Timepoint 5 (t5 = mean of the measurements recorded from minute 21-30 of the 30-minute footbath)

    Pressure Rate Product (PRP), calculated from systolic blood pressure (measured with the Mobil-O-Graph® PWA) and heart rate (measured with the Bittium Faros 360TM ECG recorder) at timepoint 5 (t5 = mean of the measurements recorded from minute 21 to minute 30 of the footbath).

Secondary outcomes

  1. Change in Pressure Rate Product (PRP) at timepoints t1 (minute 1-10 of the pre-intervention rest period), t3 (minute 1-10 of the footbath), t4 (minute 11-20 of the footbath), and t7 (minute 1-10 of the post-intervention rest period).

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    Pressure Rate Product (PRP), calculated from systolic blood pressure (measured with the Mobil-O-Graph® PWA) and heart rate (measured with the Bittium Faros 360TM ECG recorder) at timepoints t1 (t1 = mean of the measurements recorded from minute 1 to minute 10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1 to minute 10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11 to minute 20 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1 to minute 10 of the post-intervention rest period).

  2. Heart rate variability (HRV) analysis: Change in SDNN

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    SDNN: Standard deviation of normal to normal (NN) intervals (ms) (Bittium Faros 360TM ECG recorder). Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  3. Change in pNN50

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    pNN50: Percentage of successive NN intervals that differ from each other by more than 50 ms (%) (Bittium Faros 360TM ECG recorder). Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  4. Change in HF

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    HF: High frequency power band (0.15-0.40 Hz) (ms2) from frequency domain analysis (Bittium Faros 360TM ECG recorder). Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  5. Change in LF

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    LF: Low frequency power band (0.04-0.15 Hz) (ms2) from frequency domain analysis (Bittium Faros 360TM ECG recorder). Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  6. Change in LF/HF ratio

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    LF/HF ratio = ratio of two bands from frequency domain analysis: LF band (0.04-0.15 Hz), HF band (0.15-0.40 Hz) (Bittium Faros 360TM ECG recorder). Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  7. Change in VLF

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    VLF: Very low frequency power band (0.0033-0.04 Hz) (ms2) from frequency domain analysis (Bittium Faros 360TM ECG recorder). Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  8. Change in Mean Heart Rate

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    Mean heart rate (bpm) (Bittium Faros 360TM ECG recorder). Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  9. Change in SD2/SD1 ratio

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    SD2/SD1 ratio, derived from Poincaré plot (Bittium Faros 360TM ECG recorder). Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  10. Change in Stress Index

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    Stress Index (SI) according to Baevsky's formula SI = AMo/2Mo*MxDMn (Mo = mode, AMo = mode amplitude, MxDMn = variation range of RR intervals) (Bittium Faros 360TM ECG recorder). Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  11. Change in Respiration Rate

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    Respiration rate (1/min) (Bittium Faros 360TM ECG recorder). Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  12. Change in Heart Rate/Respiration Rate ratio

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    Heart rate/respiration rate ratio (Bittium Faros 360TM ECG recorder). Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  13. Change in RMSSD

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    RMSSD: Root mean square of successive differences (ms) (Bittium Faros 360TM ECG recorder). Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  14. Change in Stiffness Index

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    Stiffness Index, measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  15. Change in Perfusion Index

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    Perfusion Index, measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  16. Change in Peak to Peak Time

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    Peak to Peak Time (PPT, ms), measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  17. Change in SlopeInW1

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    SlopeInW1, measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  18. Change in SlopeInW2

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    SlopeInW2, measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  19. Change in SlopeInW3

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    SlopeInW3, measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  20. Change in SlopeInW4

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    SlopeInW4, measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  21. Change in Reflection Index

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    Reflection Index, measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  22. Change in TimeTX

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    TimeTX (ms), measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  23. Change in TimeTY

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    TimeTY (ms), measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  24. Change in QuotTYTX

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    QuotTYTX, measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  25. Change in AreaAX

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    AreaAX, measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  26. Change in AreaAY

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    AreaAY, measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  27. Change in QuotAYAX

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    QuotAYAX, measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  28. Change in TimeTV

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    TimeTV (ms), measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  29. Change in TimeTW

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    TimeTW (ms), measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  30. Change in QuotTVTW

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    QuotTVTW, measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  31. Change in AreaAV

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    AreaAV, measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  32. Change in AreaAW

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    AreaAW, measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  33. Change in QuotAVAW

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    QuotAVAW, measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  34. Change in Oxygen Saturation

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    Oxygen saturation (SpO2, %), measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  35. Change in Pulse Transit Time

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    Pulse Transit Time (PTT, ms), measured with the Vitaguard® VG 3100 monitor, getemed, Germany. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  36. Change in Systolic Blood Pressure

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    Systolic Blood Pressure (mmHg), measured with the Mobil-O-Graph® PWA. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  37. Change in Diastolic Blood Pressure

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    Diastolic Blood Pressure (mmHg), measured with the Mobil-O-Graph® PWA. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  38. Change in Mean Arterial Pressure

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    Mean Arterial Pressure (mmHg), measured with the Mobil-O-Graph® PWA. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  39. Change in Pulse Pressure

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    Pulse Pressure (mmHg), measured with the Mobil-O-Graph® PWA. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  40. Change in Stroke Volume

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    Stroke Volume (ml), measured with the Mobil-O-Graph® PWA. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  41. Change in Cardiac Output

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    Cardiac Output (l/min), measured with the Mobil-O-Graph® PWA. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  42. Change in Peripheral Resistance

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    Peripheral Resistance, measured with the Mobil-O-Graph® PWA. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  43. Change in Cardiac Index

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    Cardiac Index, measured with the Mobil-O-Graph® PWA. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  44. Change in Augmentation Pressure

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    Augmentation Pressure (mmHg), measured with the Mobil-O-Graph® PWA. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  45. Change in Augmentation Index

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    Augmentation Index, measured with the Mobil-O-Graph® PWA. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  46. Change in Pulse Wave Velocity

    Time frame: Physiological parameters are measured continuously (Vitaguard® VG 3100, GETEMED; Bittium Faros 360TM) and every 2 min (Mobil-O-Graph® PWA) for a total duration of 50 min.

    Pulse Wave Velocity (PWV, m/s), measured with the Mobil-O-Graph® PWA. Measurements analysed at timepoints t1 (t1 = mean of the measurements recorded from minute 1-10 of the pre-intervention rest period), t3 (t3 = mean of the measurements recorded from minute 1-10 of the footbath), t4 (t4 = mean of the measurements recorded from minute 11-20 of the footbath), t5 (t5 = mean of the measurements recorded from minute 21-30 of the footbath), and t7 (t7 = mean of the measurements recorded from minute 1-10 of the post-intervention rest period).

  47. Change in warmth perception at the feet

    Time frame: Immediately before (timepoint 2, t2), immediately after (timepoint 6, t6) and 10 minutes following the footbath (timepoint 8, t8) (length of footbath is up to 30 minutes).

    Self-reported warmth perception at both feet, assessed with the "Herdecke warmth perception questionnaire" immediately before (timepoint 2, t2), immediately after (timepoint 6, t6) and 10 minutes following the footbath (timepoint 8, t8). Each item is scored 0-4 (0 = cold; 4 = hot), yielding a mean between 0 and 4.

  48. Change in warmth perception at the hands

    Time frame: Immediately before (timepoint 2, t2), immediately after (timepoint 6, t6) and 10 minutes following the footbath (timepoint 8, t8) (length of footbath is up to 30 minutes).

    Self-reported warmth perception at both hands, assessed with the "Herdecke warmth perception questionnaire" immediately before (timepoint 2, t2), immediately after (timepoint 6, t6) and 10 minutes following the footbath (timepoint 8, t8). Each item is scored 0-4 (0 = cold; 4 = hot), yielding a mean between 0 and 4.

  49. Change in warmth perception at the head

    Time frame: Immediately before (timepoint 2, t2), immediately after (timepoint 6, t6) and 10 minutes following the footbath (timepoint 8, t8) (length of footbath is up to 30 minutes).

    Self-reported warmth perception at the head, assessed with the "Herdecke warmth perception questionnaire" immediately before (timepoint 2, t2), immediately after (timepoint 6, t6) and 10 minutes following the footbath (timepoint 8, t8). Each item is scored 0-4 (0 = cold; 4 = hot), yielding a mean between 0 and 4.

  50. Change in overall warmth perception

    Time frame: Immediately before (timepoint 2, t2), immediately after (timepoint 6, t6) and 10 minutes following the footbath (timepoint 8, t8) (length of footbath is up to 30 minutes).

    Self-reported overall warmth perception, assessed with the "Herdecke warmth perception questionnaire" immediately before (timepoint 2, t2), immediately after (timepoint 6, t6) and 10 minutes following the footbath (timepoint 8, t8). The item is scored 0-4 (0 = cold; 4 = hot).

  51. Change in general well-being

    Time frame: Immediately before (timepoint 2, t2), immediately after (timepoint 6, t6) and 10 minutes following the footbath (timepoint 8, t8) (length of footbath is up to 30 minutes).

    Self-reported well-being, assessed with the "Basler Befindlichkeits-Skala" (Basel Mood Questionnaire, BBS) immediately before (t2), immediately after (t6) and 10 minutes following the footbath (t8) (BBS: 16 items; 7-point rating scale; higher values represent a better outcome).

  52. Change in feeling of comfort during footbath

    Time frame: Immediately before the footbath (timepoint 2, t2), every 6 minutes during the 30-minute footbath, and 10 minutes following the footbath (timepoint 8, t8).

    Self-reported footbath comfort, assessed with a 7-point face scale ranging from "very comfortable" (laughing face) to "very hard stress" (crying face).

Other outcomes

  1. Change in warmth perception and skin stimulus at the feet during the footbath

    Time frame: Up to 30 minutes.

    Self-reported perception of warmth and skin stimulus during the footbath, assessed with a dynamic warmth and skin stimulus visual analog scale (VAS), applied once per minute (0 = cold/no stimulus; 10 = very hot/very strong stimulus).

  2. Preferred footbath

    Time frame: 10 minutes.

    Self-reported personal preference of footbath, assessed with a short questionnaire asking which footbath had the most positive overall effect (check boxes to mark for the first, second, third, or fourth footbath) and why (short, self-formulated statement of reasons). Assessed once after the fourth footbath intervention.

Sponsors and collaborators

Lead sponsor

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Other

Collaborators

  • Universität Tübingen

Registry information

Official study title

Temperature-dependent Changes in Cardiovascular Parameters During Warm Water Footbaths in Healthy Female Volunteers - a Blinded, Randomized, Controlled, Four-arm Study With Cross-over Design

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 8, 2020
Registry last updated
Jul 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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